Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Rho-Kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon
This study is currently recruiting participants.
Verified by Johns Hopkins University, July 2007
Sponsored by: Johns Hopkins University
Information provided by: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00498615
  Purpose

Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or toes. Patients often continue to experience problems despite current available treatment. Our study will investigate the use of a new vasodilator called Fasudil, a Rho-kinase inhibitor. Our hypothesis is that Fasudil will prevent vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold exposure and will therefore improve digital blood flow and skin temperature recovery time following cold challenge. These data will provide the rationale for a more elaborate clinical trials in real life situations.


Condition Intervention Phase
Raynaud's
Drug: Fasudil
Phase III

Drug Information available for: Fasudil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Efficacy, Tolerability and Biology of a Rho-Kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The time to recover 50% and 70% of fall in the baseline skin temperature. [ Time Frame: within 60 minutes following cold challenge ]

Secondary Outcome Measures:
  • - The blood flow profile changes as determined by Laser Doppler scans of the fingers [ Time Frame: within the time frame of the cold challenge recovery period ]

Estimated Enrollment: 24
Study Start Date: April 2007
Estimated Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of scleroderma
  • Definite Raynaud's

Exclusion Criteria:

  • symptomatic orthostatic hypotension
  • evidence of current malignancy
  • active ischemic digital ulcer and/or tissue gangrene
  • history of sympathectomy at any time
  • upper extremity deep vein thrombosis or lymphedema within 3 months of the study
  • recent surgical procedure requiring general anesthesia
  • current alcohol or illicit drug use
  • use of any investigational drug within 30 days of the study sessions
  • pregnancy or current breast feeding
  • subjects felt by the investigators to active disease that would affect their ability to safely participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498615

Contacts
Contact: Regina Greco, R.N. 410-550-2629 rniedzw1@jhmi.edu
Contact: Pam S Hill 410-550-2003 ph@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Fredrick M Wigley, M.D.     410-550-2003     ph@jhmi.edu    
Principal Investigator: Fredrick M Wigley, M.D.            
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Fredrick M Wigley, M.D. Johns Hopkins University
  More Information

Study ID Numbers: NA_00002801
Study First Received: July 6, 2007
Last Updated: July 10, 2007
ClinicalTrials.gov Identifier: NCT00498615  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
scleroderma
Raynaud's phenomenon
Rho-kinase inhibitor

Study placed in the following topic categories:
Calcium, Dietary
Peripheral Vascular Diseases
Raynaud Disease
Vascular Diseases
Fasudil

Additional relevant MeSH terms:
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009